This review concluded that paclitaxel-eluting stents improved clinical outcomes in people with ST-segment elevation myocardial infarction, with a decreased need for revascularisation and no safety concerns. A lack of reporting of some review methods and a lack of quality assessment made the validity of included data uncertain, hence the conclusions should be treated with caution.

To assess the long term clinical efficacy of paclitaxel eluting stents in people with ST-segment elevation myocardial infarction (STEMI).

PubMed, EMBASE, Web of Science and Cochrane Central Register of Controlled Trials (CENTRAL) were searched to May 2009. Search terms were not reported. Conference proceedings of three relevant societies and five relevant websites were checked.

Randomised controlled trials (RCTs) with follow-up of more than six months that compared paclitaxel-eluting stents to bare-metal stents in people with STEMI were eligible for inclusion. Outcomes of interest were mortality, recurrent myocardial infarction, stent thrombosis (angiographically proven) and repeat revascularisation.

In the included studies some participants received glycoprotein IIb/IIIa inhibitors (with or without heparin), thrombolytics, abciximab or bivaludin. All participants were recommended antiplatelet therapy with indefinite aspirin and thienopyridine from six months to 12 months after procedure. Most studies followed up for at least one year; one trial followed-up for seven months.

Two reviewers appear to have assessed studies for inclusion. Disagreements were resolved by consensus.

The authors did not state that they assessed validity.

Data were extracted and odds ratios (OR) and 95% confidence intervals (CI) were calculated.

The authors did not state how many reviewers performed data extraction.

Where there was no significant heterogeneity, pooled odds ratios and 95% CI were calculated using a fixed-effect model; otherwise a random-effects model was used. Heterogeneity was assessed using Cochran's test and I². Publication bias was assessed using funnel plots and the adjusted rank correlation test.

Six trials (4,190 participants) were included. One trial had 3,006 participants and others ranged from 80 to 619 participants. Overall 2,846 were randomised to paclitaxel-eluting stents.

Tests showed no evidence of publication bias.

Compared to bare-metal stents, paclitaxel-eluting stents had no effect on mortality, recurrent myocardial infarction and stent thrombosis with no evidence of heterogeneity.

Paclitaxel-eluting stents were associated with a reduced risk of revascularisation (OR 0.56, 95% CI 0.44 to 0.72, I²=5.5%).

Paclitaxel-eluting stents improved clinical outcomes in people with STEMI, with a decreased need for revascularisation and no safety concerns.

The aims of the review were clearly stated in terms of the inclusion criteria. A range of sources was searched. Unpublished studies were sought, which was likely to have reduced the possibility of publication bias. It was unclear whether there were language restrictions and so risks of language bias were unknown. Search terms were not reported, so the reliability of the search was unknown. Tests for publication bias may have been unreliable with the limited number of available studies. Methods of study selection aimed at reduced reviewer error and bias. Methods for data extraction were not described. The authors did not report any assessment of the quality of included studies and so it was not possible to comment on the validity of included data. The methods of synthesis appeared appropriate. Heterogeneity was assessed. Little information was given about the included participants and (as the authors commented) it may not be appropriate to generalise the results to all people with acute myocardial infarction.

Concerns about a lack of reporting of some review methods and the unclear validity of the included data mean that the authors' conclusions should be treated with caution.

Practice: The authors did not state any implications for practice.

Research: The authors stated that further RCTs were necessary to assess the long-term outcomes associated with paclitaxel-eluting stents in people with STEMI.

None stated.

This is a critical abstract of a systematic review that meets the criteria for inclusion on DARE. Each critical abstract contains a brief summary of the review methods, results and conclusions followed by a detailed critical assessment on the reliability of the review and the conclusions drawn.